Model Number 4515-70-107 |
Device Problem
Device Slipped (1584)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 01/01/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.Device manufacture date is unknown.The device serial or lot number is unknown.Reporter¿s complete mailing address is not available.Reporter¿s phone number is not available.The device serial or lot number was unknown; therefore, udi: (b)(4).
|
|
Event Description
|
It was reported that during a cadaver lab training, the array clamp device broke during use.It was reported that it was still able to hold the array, however, it was not stable and moved during the demonstration.It was reported that the demonstration could not be continued since the array moving made it difficult to continue with the case.This event did not occur during surgery.There was no patient involvement.There were no reports of injuries, medical intervention or prolonged hospitalization.The exact date of this event was unknown but was noted to have occurred in 2021.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
|
|
Manufacturer Narrative
|
Product complaint # : (b)(4).Investigation summary : after multiple requests, the customer has not returned the device for evaluation / repair to any jnj site and therefore the complaint cannot be confirmed, and no conclusion can be drawn at this time.The complaint will be reopened upon receiving the device for repair from the customer.Device history lot : the product investigation found no evidence suspecting an error in the manufacturing or material that would be a contributing factor in the reported allegation(s).A manufacturing records evaluation (mre) was not performed.
|
|
Search Alerts/Recalls
|
|